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Completed

NCT Number: NCT05625880

Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.

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Key information

Conditions

Jaundice, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, 45200, Nepal

About this study

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants born with gestational age ≥35 weeks
  • Birth weight ≥ 1750g
  • Age 1 - ≤14 days
  • Infants that will have a blood sample draw

Exclusion criteria

  • Infants in the need for respiratory support
  • Infants with conditions that could compromise skin circulation, as sepsis, heart failure
  • Infants that have received phototherapy

Treatment and study plan

Picterus Jaundice Pro

Device

Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place

Other names: Picterus JP

Primary outcomes

  1. Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

    Time frame: 5-10 minutes

    Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns at Dhulikhel Hospital, Kathmandu Nepal.

Secondary outcomes

  1. correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn

    Time frame: 1-2 hours

    To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice

  2. correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns

    Time frame: 5-10 minutes

    To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice

  3. Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns

    Time frame: 5-10 minutes

    To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Sponsors and collaborators

Lead sponsor

Picterus AS

Industry

Collaborators

  • Dhulikhel Hospital
  • National Taiwan Normal University
  • St. Olavs Hospital

Registry information

Official study title

Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2022
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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